EAST BRUNSWICK, N.J.--(BUSINESS WIRE)--Dec 13, 2007 - Savient
Pharmaceuticals, Inc. (NASDAQ:SVNT) is pleased to announce
statistically significant positive results for the Puricase
(pegloticase) Phase 3 program in treatment-failure gout patients,
which has been conducted under the auspices of a Special Protocol
Assessment (SPA) with the U.S. Food and Drug Administration (FDA).
Puricase 8 mg administered by a two-hour intravenous infusion every
two weeks or every four weeks met the primary efficacy endpoint in
the Intent to Treat (ITT) and Per Protocol analyses in each of two
replicate, six-month Phase 3 clinical trials, (the studies are
termed, Gout Outcomes and Urate Therapy, GOUT 1 and GOUT 2). The
primary efficacy endpoint specified under the Special Protocol
Assessment was normalization of plasma uric acid during months
three and six of the clinical trials. Moreover, the every two week
dose group also attained statistical significance for the a priori
definition of reduction of gout tophi in the pre-specified pooled
analysis, while the every four week dose group revealed a favorable
numerical trend for this secondary endpoint. Analysis of other
secondary efficacy endpoints also showed favorable numerical trends
in one or both pegloticase dose groups. There were no expedited
reports of serious adverse events during the Phase 3 trials.

The treatment-failure gout population is characterized by very
severe gout symptoms such as frequent crippling gout flares and
gout tophi representing progressive disease, as well as a very high
degree of co-morbidity such as hypertension, cardiovascular
disease, diabetes, kidney disease, obesity, osteoarthritis and,
medical histories of multiple drug hypersensitivities and diverse
environmental allergies. The combination of advanced disease
progression, important co-morbidities requiring polypharmacy, and
multiple allergic histories makes this population exceptionally
difficult to treat in clinical practice today.

"Our initial impression of the pegloticase Phase 3 top line data
is very favorable," said Zeb Horowitz, MD., Sr. Vice President and
Chief Medical Officer. "We believe that the Savient GOUT studies
are very important in two regards. We believe that the Phase 3 data
show that pegloticase has the potential to be the first effective
therapeutic option to control uric acid in treatment-failure gout
patients. Second, we believe that our assessment of tophi in GOUT 1
and GOUT 2 by digital photography and image analysis uniquely
demonstrates the attainment of a statistically significant and
medically relevant clinical outcome, in this most difficult to
treat gout patient population."

The Phase 3 results confirm that the pre-specified primary
efficacy endpoint for both pegloticase treatment arms was met in
each placebo-controlled study in the ITT analysis. In the ITT
analysis of the primary endpoint all discontinued patients were
imputed as non-responders, making this a very conservative
assessment of therapeutic response. The mean responder rate for the
every two week dose group pooled across both studies was 42% (p is
less than 0.001) and the mean responder rate for the every four
week dose group was 35% (p is less than 0.001). In the Per Protocol
analysis the responder rates were higher: every two week was 61% (p
is less than 0.001), and every four week was 50% (p is less than
0.001). The placebo responder rate was zero in both trials for both
the ITT and Per Protocol analyses.

We believe that the most clinically important of the secondary
efficacy outcomes assessed in these studies was the effect of
pegloticase on gout tophi. The every two week dose arm attained
statistical significance in the pre-specified pooled analysis (p
equal to 0.005) for the elimination of gout tophi (complete
elimination of at least one tophus and no new tophi), whereas the
every four week dose group did not attain statistical
significance.

Although many secondary efficacy endpoints were explored in this
Phase 3 program, we have not yet finished analyzing this aspect of
the data base, and thus cannot include these in the top line
results. It appears that in some statistical analyses significance
was observed and in others, favorable numerical trends were
noted.

As anticipated, patients in both dose arms showed an increase in
gout flares as compared to placebo only in the early study period.
However, in the last three months of the study period both
pegloticase dose arms showed reduced gout flare frequency compared
to the first three months, but not attaining statistical
significance relative to placebo. The numerical trend toward
reduction of gout flare frequency below the placebo rate is
considered favorable. Despite the pre-study history of frequent
severe gout flares and the evidence that pegloticase treatment, as
any other uric acid lowering treatment, initially induces gout
flares in susceptible patients, unlike other uric acid lowering
therapies the increase in gout flares induced by pegloticase
appears to persist only during the early portion of the treatment
period.

"We believe that achieving positive results for controlling uric
acid level and elimination of gout tophi in this difficult to treat
gout population indicates that pegloticase provides a clinically
important advancement in managing hyperuricemia in patients with
treatment-failure gout," commented Christopher Clement, President
and Chief Executive Officer of Savient. "New approaches are long
over due for patients who suffer from this painful and potentially
crippling disease. We estimate that there are 25,000 to 100,000
treatment failure patients in the United States and currently these
patients have no alternative therapeutic options other than
symptomatic relief. If approved by the FDA, pegloticase would be
the first new therapy for treating this disease in over forty
years, and the only treatment to demonstrate control of plasma uric
acid in the treatment-failure patients."

Throughout the study period patient safety was assessed by
frequent review of adverse events and laboratory findings, and
real-time assessment of serious adverse events (SAEs). No signal
for adverse safety findings has appeared in preliminary analysis of
the unblinded data set, except for the occurrence of
infusion-related adverse events.

Three deaths occurred in the treatment phase of the pooled ITT
population, including death in one patient who voluntarily withdrew
consent for renal dialysis. (A fourth patient, not included in the
ITT population, died after completing the study when she elected to
withdraw from antibiotic treatment of MRSA sepsis.) None of the
patient deaths appear to be causally related to pegloticase
treatment, as judged by the clinical investigators and Savient
medical monitors.

In the pooled ITT population, infusion reactions occurred at
some time during the studies in 56 pegloticase treated patients
(33%): 22 were in the every two week dose group and 34 were in the
every four week dose group. Two placebo patients (5%) experienced
an infusion reaction. Typically, an infusion reaction involved back
or chest pain, muscle cramps, sweating, and flushing. Infusion
reactions were most often mild or moderate in severity and usually
controlled by slowing the infusion rate and/or giving
diphenhydramine. However, infusion reactions could be severe,
especially in terms of chest or back pain. Nineteen patients (11%
of pegloticase treated patients) experienced an infusion reaction
termed serious or severe: 6 in the every two week group and 13 in
the every four week group. Sixteen patients (9%) reported infusion
reaction as the reason for withdrawal from the studies, 8 patients
in each of the every two week and every four week dose groups.

The occurrence of infusion reactions as a proportion of total
infusions administered in the pooled ITT population is another way
to view this adverse event representing lack of tolerability. The
number of infusion reactions as a proportion of all infusions
administered was 5% (43/851) for the every two week dose group, 8%
(70/846) for the every four week dose group, and 0.8 % (4/502) for
the placebo group.

Infusion reactions that involved symptoms of transient lingual
swelling, peri-oral edema, wheezing, or hypotension occurred in two
patients in each treatment group, or 2.4% of patients who were
exposed to pegloticase. Only one of the four patients was
administered epinephrine and two were administered corticosteroids.
All patients recovered fully, some very rapidly and others within
approximately 60 minutes. None of the four were re-challenged and
all withdrew. Although we continue to have uncertainty as to
whether some or all of these patients actually experienced an
anaphylactic reaction to the drug, these symptoms have been
interpreted to represent anaphylaxis in other drug programs and may
be interpreted so in the GOUT trials as well.

In one circumstance, a multiply allergic patient developed
urticaria five days after pegloticase dose administration. Although
suggestive of delayed type hypersensitivity, the multiply allergic
condition of this patient and other factors makes assigning
causality to any level of certainty difficult.

"We believe that the statistically sound and clinically
meaningful results of the Phase 3 program in this difficult to
treat gout population, most of whom have severe, progressive
disease, are tremendously encouraging," said Dr. Horowitz. "We
embarked on these gout trials using new methods and new endpoints
in a population for whom no therapy is currently available. Both
dose arms met the test of statistical significance for the
normalization of plasma uric acid in both trials in the ITT and Per
Protocol analyses. Moreover, we believe that the success of the
pre-specified pooled analysis for the every two week dose group for
the effect on gout tophi is of great importance, because the
presence of gout tophi is considered to be a hallmark of advanced
disease progression.

"Our early analysis of safety results appears to be favorable,
with recognition that some patients may not be able to tolerate
pegloticase infusions due to unacceptably severe infusion
reactions," continued Dr. Horowitz. "We believe that this safety
risk is manageable in the clinical practice setting, as it is for
other biologics, because it is anticipated that only qualified
specialists and trained infusion nurses will be involved in the
administration of pegloticase. Still pending are the extensive and
complex analyses of immunological assessments. In summary, we
believe that the preliminary top line results indicate a favorable
risk-benefit ratio justifying the use of pegloticase to control
hyperuricemia and potentially to control the clinical consequences
of hyperuricemia in the treatment-failure gout population."

The company plans to file a Biologics Licenses Applications
(BLA) with the FDA in 2008 based on the positive results from its
Phase 3 trials, following a pre-BLA meeting with the reviewing
Division.

ABOUT PURICASE (pegloticase)

Puricase (pegloticase) is a pegylated recombinant mammalian
urate oxidase, in development to control hyperuricemia and its
clinical consequences in patients for whom conventional therapy is
contraindicated or has been ineffective. The two Phase 3 pivotal
trials assessed the safety and efficacy of a six-month course of
pegloticase therapy in patients with treatment-failure gout, under
the auspices of a Special Protocol Assessment from the U.S. Food
and Drug Administration. Savient has licensed worldwide rights to
the technology related to Puricase (pegloticase) from Duke
University and Mountain View Pharmaceuticals, Inc. Puricase is a
registered trademark of Mountain View Pharmaceuticals, Inc.

ABOUT THE TREATMENT-FAILURE GOUT POPULATION

Approximately three to five-million Americans suffer from gout,
many of whom experience only limited success in the long term
management of their painful symptoms. Within this group, we
estimate that allopurinol, the mainstay of therapy for control of
uric acid, is contraindicated or has failed to achieve therapeutic
success at appropriate dosages in approximately 25,000 to 100,000
patients, meaning that today tens of thousands of gout patients
have no effective treatment option. It is for these
treatment-failure patients that pegloticase potentially offers a
unique benefit and for which the product has been granted Orphan
drug designation.

CONFERENCE CALL

Savient Pharmaceuticals, Inc. Senior Management will hold a
one-hour conference call to answer questions related to this
announcement on December 13th, 2007 at 8:00 a.m. Eastern Time.
Those interested in listening to the conference call live via the
Internet may do so by visiting the Investor Relations section of
Savient Pharmaceuticals' website at www.savientpharma.com. The
webcast will be available for 14 days on the Company website
beginning approximately one hour after the conclusion of the
conference call.

A telephone replay will be available from 11:00 a.m. Eastern
time on December 13th through December 23rd at 11:59 p.m. Eastern
time by dialing (800) 642-1687 (domestic) or (706) 645-9291
(international) and entering conference ID number 27984783.

ABOUT SAVIENT PHARMACEUTICALS, INC.

Savient Pharmaceuticals is a biopharmaceutical company engaged
in developing and distributing pharmaceutical products that target
unmet medical needs in both niche and broader markets. The
company's product development candidate, Puricase (pegloticase) for
treatment-failure gout, has reported positive Phase 1 and 2
clinical data. Patient dosing in the Phase 3 clinical studies began
in June 2006; patient enrollment was completed in March 2007; and
the Phase 3 clinical studies were completed in October 2007.
Savient's experienced management team is committed to advancing its
pipeline and expanding its product portfolio by in-licensing
late-stage compounds and exploring co-promotion and co-development
opportunities that fit the Company's expertise in specialty
pharmaceuticals and biopharmaceuticals with an initial focus in
rheumatology. Savient also manufactures and supplies Oxandrin(R)
(oxandrolone tablets, USP) CIII in the U.S. Puricase is a
registered trademark of Mountain View Pharmaceuticals, Inc. Further
information on Savient can be accessed by visiting:
http://www.savient.com.

FORWARD-LOOKING LANGUAGE

It is important to note that in reporting these preliminary
results the Company is reporting its views and opinions regarding
the preliminary data and that the Company cannot forecast how the
FDA or other regulatory authorities will view or consider the data
upon review, or how any of the data set will be translated into
label language, if approved. FDA typically conducts its own
analyses from the original data sets and possibly may come to
different conclusions than Savient has reached. Furthermore, the
data reported here are preliminary data in as much as these are
initial results, still to be extensively analyzed for possible
inconsistencies and errors.

This news release contains forward-looking statements that are
subject to certain risks, trends and uncertainties that could cause
actual results and achievements to differ materially from those
expressed in such statements. These risks, trends and uncertainties
are in some instances beyond Savient's control. Words such as
"anticipate," "believe," "estimate," "expect," "intend," "plan,"
"will" and other similar expressions help identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. These forward-looking statements involve
important risks and uncertainties and are based on current
expectations, assumptions, estimates and projections about
Savient's business and the biopharmaceutical and specialty
pharmaceutical industries in which Savient operates.
Forward-looking statements in this news release include, without
limitation, statements regarding the results of Savient's two
pivotal six month Phase 3 clinical trials for Puricase(R)
(pegloticase), the filing of a Biologics License Application with
the FDA and the absence of other therapies to treat gout. Important
factors that may affect Savient's ability to achieve the matters
addressed in these forward-looking statements include, but are not
limited to, Savient's stock price and market conditions, delay or
failure in developing Puricase (pegloticase) delay in achieving or
failure to achieve FDA approval of Puricase (pegloticase),
difficulties of expanding Savient's product portfolio through
in-licensing, fluctuations in buying patterns of Oxandrin(R),
potential future returns of Oxandrin or other products, Savient's
continuing to incur substantial net losses for the foreseeable
future, difficulties in obtaining financing, potential development
of alternative technologies or more effective products by
competitors, reliance on third-parties to manufacture, market and
distribute Savient's products, economic, political and other risks
associated with foreign operations, risks of maintaining protection
for Savient's intellectual property, risks of an adverse
determination in ongoing or future intellectual property
litigation, risks associated with stringent government regulation
of the biopharmaceutical industry and the other risks discussed or
referenced in our most recent annual report on Form 10-K, quarterly
report on Form 10-Q and other current reports, each filed by
Savient with the SEC. Savient may not actually achieve the plans,
intentions or expectations disclosed in Savient's forward-looking
statements. Actual results or events could differ materially from
the plans, intentions and expectations disclosed in the
forward-looking statements that Savient makes. Stockholders should
not place undue reliance on the forward-looking statements, which
speak only as to the date of this press release. Savient's
forward-looking statements do not reflect the potential impact of
any future acquisitions, mergers, dispositions, joint ventures or
investments that Savient may make. Savient does not assume any
obligation to update any forward-looking statements.